Tuttnauer ELV-D Manual

OPERATION
&
MAINTENANCE
MANUAL
Laboratory Vertical Steam Sterilizers
models 5050, 5075
ELV-D Standard Autoclave
ELVC-D Including Fast Cooling System
Cat. No. MAN205-0451001EN Rev B
Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: [phone]
Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. Tel [phone],
Fax: [phone]

Page 1 of 83 Pages
TABLE OF CONTENTS
PARAGRAPH PAGE NO.
1. GENERAL ............................................................................................................4
1.1 Incoming Inspection....................................................................................4
1.2 Warranty......................................................................................................4
1.3 Warranty Statement.....................................................................................4
1.4 Accessories...................................................................................................5
2. SAFETY INSTRUCTIONS ..................................................................................6
3. TECHNICAL DATA.............................................................................................8
3.1 Introduction.................................................................................................8
3.2 Operating Conditions...................................................................................9
3.3 Directives and Standards.............................................................................9
3.4 Environment Emission Information .........................................................10
3.5 Electrical Data...........................................................................................10
3.6 Specifications.............................................................................................10
3.7 Construction ..............................................................................................10
3.8 Loading Capacities ....................................................................................11
3.9 Utilities.......................................................................................................11
3.10 Symbol Description....................................................................................12
3.11 Water Quality.............................................................................................16
3.12 Safety Features ..........................................................................................17
3.13 Description of Operation ...........................................................................18
4. CONTROL PANEL ............................................................................................19
4.1 Description and Functions of the Front Panel Keyboard.........................20
4.2 Displayed Error Messages / Symbols.........................................................22
4.3 Displayed operational messages / Symbols................................................23
5. STERILIZATION PROGRAMS.........................................................................24
5.1 Program 1: Unwrapped instruments.........................................................25
5.2 Program 2: Wrapped instruments .............................................................26
5.3 Program 3: Unwrapped pouches...............................................................27
5.4 Program 4: Wrapped pouches ...................................................................28
5.5 Program 5: Unwrapped delicate instruments............................................29
5.6 Program 6: Wrapped delicate instruments................................................30
5.7 Program 7: Custom 1.................................................................................31
5.8 Program 8: Custom 2.................................................................................32
5.9 Program 9: Liquid A..................................................................................33
5.10 Program 10: Liquid B................................................................................34
6. CHECKING AND CHANGING PARAMETERS AND OTHER DATA...........35
6.1 Directories and subdirectories...................................................................35
6.2 Table of parameters...................................................................................36

Page 2 of 83 Pages
6.3 Entering the main menu............................................................................37
6.4 Cycle Parameters (Custom 1)....................................................................39
6.5 System Parameters.....................................................................................45
6.6 History........................................................................................................48
6.7 Maintenance ..............................................................................................50
6.8 Advanced Options......................................................................................55
6.9 Version information...................................................................................58
7. SCREENS...........................................................................................................61
7.1 Screens following a complete successfully cycle – "Cycle Ended" ..........61
7.2 Screens following aborted cycles after complete sterilization stage..........62
7.3 Screens following a fail cycle:...................................................................63
8. PRINTER............................................................................................................64
8.1 Printer Output............................................................................................64
8.2 Printer Handling........................................................................................66
9. PREPARATION BEFORE STERILIZATION..................................................69
9.1 Instruments................................................................................................69
9.2 Liquids .......................................................................................................70
9.3 Loading......................................................................................................70
10. OPERATION......................................................................................................71
10.1 Turning on the autoclave...........................................................................71
10.2 Opening the door .......................................................................................71
10.3 Loading......................................................................................................72
10.4 Selecting program......................................................................................72
10.5 Closing the door.........................................................................................72
10.6 Starting cycle .............................................................................................72
10.7 Unloading ..................................................................................................72
10.8 Stopping the process and cancelling the ERROR message.......................73
10.9 Start Cycle by Clock mode.........................................................................73
10.10Moving the Autoclave................................................................................73
10.11Loading and Unloading the Device...........................................................73
11. DOOR SAFETY SYSTEM..................................................................................75
11.1 Pressure switch and Locking solenoid ......................................................75
12. SERVICE AND MAINTENANCE.....................................................................76
12.1 Preventive Maintenance ............................................................................76
12.2 Checking the Safety Valve.........................................................................77
13. TROUBLESHOOTING......................................................................................79
14. SPARE PARTS LIST..........................................................................................83
15. ACCESSORIES..................................................................................................83

Page 3 of 83 Pages
TABLE OF CONTENT (Cont.)
DRAWINGS PAGE NO.
FRONT VIEW .............................................................................................................13
REAR VIEW................................................................................................................14
OVERALL DIMENSIONS DRAWING (mm).............................................................15
CONTROL PANEL DRAWING..................................................................................19
BASKETS AND CONTAINERS .................................................................................82

Page 4 of 83 Pages
1. GENERAL
1.1 Incoming Inspection
The autoclave should be unpacked and inspected for mechanical damage
upon receipt. Observe packing method and retain packing materials until
the unit has been inspected. Mechanical inspection involves checking for
signs of physical damage such as: scratched panel surfaces, broken knobs,
etc.
If damage is apparent, contact your dealer or point of purchase, so that
they may notify the manufacturer and file a claim with the appropriate
carrier.
All Tuttnauer products are carefully inspected prior to shipment and all
reasonable precautions are taken in preparing them for shipment to assure
safe arrival at their destination.
1.2 Warranty
We certify that this instrument is guaranteed to be free from defects in
material and workmanship for one year against faulty components and
assembly with the exception of glassware, lamps and heaters.
The warranty does not include and does not replace routine treatment
and preventive maintenance to be performed according to instructions
in sec. 12.1 (Preventive Maintenance).
Our obligation is limited to replacing the instrument or parts, after our
examination, if within one year after the date of shipment they prove to be
defective. This warranty does not apply to any instrument that has been
subjected to misuse, neglect, accident or improper installation or
application, nor shall it extend to products that have been repaired or
altered outside the factory without prior authorization from us.
The Autoclave should not be used in a manner not described in this
manual!
1.3 Warranty Statement
The warranty registration must be completed and returned to our service
departments; within fourteen (14) days of purchase or the warranty will be
void.
Our Technical Service Depts can be reached at:
Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: [phone], E-mail: [email protected]
Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY 11788, USA
: [phone], [phone], Fax: [phone]
e-mail:[email protected].

Page 5 of 83 Pages
Note:
If there is any difficulty with this instrument, and the solution is not
covered in this manual, contact our representative or us first. Do not
attempt to service this instrument yourself. Describe the difficulty as
clearly as possible so we may be able to diagnose the problem and provide
a prompt solution.
If the autoclave is equipped with a printer, send along a copy of the last
printout for our inspection. If replacement parts are needed, stipulate the
model and serial number of the machine.
No products will be accepted for repair without proper authorization from
us. All transportation charges must be paid both ways by the owner. This
warranty will be void if the unit is not purchased from an authorized full
service Tuttnauer dealer.
1.4 Accessories
Basket accessories: A set of two baskets is available for the unit. The
baskets are made of stainless steel wire and have a handle. The basket
allows the operator to load a large quantity of materials into the chamber.
The pressure scale, printer option and cooling method can be set up at any
time by a technician.
Stainless steel containers: A stainless steel container, for waste products, is
available. This container has vent holes on its upper part

Page 6 of 83 Pages
2. SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand the operation
instructions before first operation of the autoclave. The following issues may
require instructions guidance provided by the manufacturer: how to operate the
autoclave, the door safety mechanism, the dangers involved in circumventing
safety means, how to ensure that the door is closed, and how to select a correct
sterilization program.
Make sure that you know where the main power switch is, where the water cut-off
valve is and where the compressed air disconnection valves (if applicable) are
located.
Autoclave maintenance is crucial for the correct and efficient function of the
device. We enclose a log booklet that includes maintenance recommendations,
with every device.
The weekly spore test is part of the preventive maintenance plan, along with the
annual validation of the sterilization processes that ensures appropriate
temperature dispersion within the chamber.
Never use the autoclave to sterilize corrosive products, such as: acids, bases and
phenols, volatile compounds or solutions such ethanol, methanol or chloroform
nor radioactive substances.
1. Never start using a new autoclave before the safety, licensing and
authorization department has approved it for use.
2. All autoclave users must receive training in proper usage from an
experienced employee. Every new employee must undergo a training
period under an experienced employee.
3. A written procedure must be established for autoclave operation,
including: daily safety tests, seal inspection and door hinge inspection,
smooth action of the closing mechanism, chamber cleaning, prevention of
clogging and preservation from corrosion, what is permitted and what is
prohibited for sterilization and choosing a sterilization program.
4. Liquids may be sterilized only with the “liquids” programs. The container
must be covered but not sealed. Sealed bottles may only be sterilized using
a special program. The bottle must be either Pyrex or a Borosilicate glass
bottle. Verify that the two temperature sensors are located inside two
different bottles to assure that the liquid temperature is 20°C below boiling
temperature for sealed bottles at the end of the cycle.
5. When sterilizing plastic materials, make sure that the item can withstand
sterilization temperature. Plastic that melts in the chamber is liable to
cause a great deal of damage.
6. Individual glass bottles may be placed within an appropriate container that
will be placed in a basket. Never place glass bottles on the floor of the
autoclave. Never fill more than 2/3 of the bottle volume.
7. On closing the autoclave's door, make sure it is properly locked before
activating.
8. Before withdrawing baskets, wear heat resistant gloves.
9. Before opening the door, verify that there is no pressure in the chamber
(chamber pressure gauge is located on the autoclave's front panel or door,
depends on model).

Page 7 of 83 Pages
10. Open the door slowly to allow steam to escape and wait 5 minutes before
you remove the load. When sterilizing liquids, wait 10 minutes.
11. Once a month, ensure that the safety valves are functioning, and once
annually a certified tester must conduct pressure chamber safety tests.
12. Once annually, or more frequently, effective tests must be performed, i.e.,
calibration and validation.
13. Examine the condition of assemblies on a regular basis. Make sure there
are no leaks, breaks, blockages, whistles or strange noises.
14. It is required to conduct maintenance operations as instructed.
15. Immediately notify the person in charge of any deviation or risk for the
proper function of the device.

Page 8 of 83 Pages
3. TECHNICAL DATA
3.1 Introduction
Models 5050 and 5075 ELV-D/ELVC-D are vertical sterilizers designed
especially for sterilization of instruments, liquids and other materials in
hospital laboratories, medical laboratories, research institutes, food
laboratories and pharmaceutical facilities.
A special feature of this sterilizer is the fast cooling operation, provided as
an option for the liquids sterilization cycle.
The sterilizer is fully automatic with a choice of ten programs (including
two custom programs), eliminating any need for operator intervention
during a cycle. The custom programs are programs that may be changed
by an authorized technician. A computerized control unit enables precise
control and monitoring of physical parameters and clear documentation of
the sterilization cycles.
The autoclave is equipped with a safety valve, which blows off at 280 kPa
(40 psi) (max. working pressure). The safety valve is located on the rear of
the autoclave. The control system provides adequate protection, to ensure
the safety of personnel and reliable operation with a minimum of down
time.
On both models, a printer is an optional addition to the autoclave. The
printer prints the preset and actual parameters of the cycle (temperature,
time and pressure/vacuum).
The autoclave is equipped with an analog pressure gauge designed for
reference only. In case that there is any problem with electricity supply
during a sterilization cycle the pressure gauge will be used to verify that
there is pressure in the chamber.
This manual provides information for the following models:
ELV-D – this is the basic model of the vertical laboratory autoclave.
ELVC-D – this model includes a cooling system that enables cycles
with fast cooling.
This manual is intended to give the user a general understanding of how
the autoclave works and indicates best ways to operate and maintain it in
order to obtain optimum results and a trouble free operation.
After reading this manual, operating the autoclave should be straight
forward. However, since the autoclave is built using high technology
sensitive components, no attempt should be made by the user or any other
unauthorized person to repair or re-calibrate it.
Only technical personnel having proper qualifications, holding technical
documentation and adequate test instrumentation, are authorized to
undertake repair or service.

Page 9 of 83 Pages
3.2 Operating Conditions
The autoclave is intended to work in ‘indoor’ conditions only.
Only autoclavable materials shall be used.
The environment shall not exceed an ambient temperature range of
5ºC (41ºF)-40ºC (104ºF) and a relative humidity of 85%
respectively.
The operation altitude shall not be over 2000 meters (6561 feet)
(ambient pressure shall not be lower than 80 kPa (11.6 psi)).
The autoclave shall not be used in a manner not specified in this
manual!
Do not use the autoclave in the presence of dangerous gases.
The packed or unpacked device shall be stored in ‘indoor’ conditions.
Operate the autoclave only in the manner specified in the manual. If
the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
Caution!
Waste water should be brought into the public net in accordance with
the local rules or requirements i.e. only non-hazardous liquids shall
be disposed in public sewage!
3.3 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
3.3.1 Technical Standards
1. AAMI/ANSI ST 8.
2. ASME Code Sec. VIII for Pressure Vessels.
3. Pressure Equipment Directive 97/23/EEC.
4. EN 285:2006 ― Sterilization , Steam sterilizers , Large
sterilizers
5. IEC/UL 61010A-1 ― electrical equipment for laboratory
use; general requirements.
6. IEC 61010-2-040 ― particular requirements for sterilizers
and washer disinfectors used to treat medical materials.
7. ISO 17665 ― 1:2006 Sterilization of health care products
moist heat.
3.3.2 Quality standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.

Page 10 of 83 Pages
3.4 Environment Emission Information
A. Peak sound level generated by the sterilizer is «70 / dBA with a back
sound level of 60 dBA.
B. Total heat transmitted by the sterilizer is < 100 W/h
3.5 Electrical Data
PROPERTIES 208V
version
230V
version
380V
version
Ampere (A) at 3Ph 24A 24A 14A
Voltage (V) 208V/3ph 230V/3ph 380V/3ph
Hertz (Hz) 50/60 Hz 50/60 Hz 50/60 Hz
Heaters power (W) 9000 9000 9000
Protection against electrical shock Class I Class I Class I
Degree of protection by enclosure IP31 IP31 IP31
3.6 Specifications
PROPERTIES MODEL
5050 5075
Chamber diameter in mm 500 500
Chamber depth in mm 520 750
Effective Chamber volume 102 lit.
27 US gal
160 lit.
42.3 US gal
Overall
dimensions
Height (mm) 950 1100
Width (mm) 866 866
Length (mm) 715 715
Maximum
dimensions
(door open)
Width (mm) 960 960
Height (mm) 1538 1688
Net weight (kg) 171 190
Shipping volume (m3) 1.35 1.35
Shipping weight (kg) 204 223
Max. Allowable Working
pressure (MAWP) 2.8 bar (40 psi)
3.7 Construction
Chamber and door material Stainless steel
Outer Cabinet Stainless Steel
Chamber insulation Fiberglass with reinforced material

Page 11 of 83 Pages
3.8 Loading Capacities
3.8.1 solid load
Maximum solid load: 7 kg (15.5 lb)
3.8.2 Erlenmeyer Flasks
Size 250 ml 500 ml 1000 ml
Qty 5050 2 x 21 2 x 14 2 x 8
5075 3 x 21 3 x 14 3 x 8
3.8.3 Medium Flasks (Schott)
Size 250 ml. 500 ml 1000 ml
Qty 5050 2 x 32 2 x 21 2 x 15
5075 3 x 32 3 x 21 3 x 15
3.9 Utilities
3.9.1 Electrical utility
Power Switch box Recommended
Circuit Breaker
208-220V (3 Ph + Earthing) No 32A
380-400V(3 Ph + Neutral +
Earthing) No 16A
230V 1ph yes 50A
Frequency 50/60Hz
3.9.2 Other utilities
Compressed Air (ELVC-D
only) 1/2" 3-4 Bar (44-58 psi)
Tap water 1/2", 2-3 Bar (29-44 psi)
Mineral free water 1/2", 2-3 Bar (29-44 psi)
Drain 2" Minimum Withstanding temp.
of 80°C (176°F)
Attention:
A switch or circuit-breaker must be included in the building
installation. This switch or circuit-breaker shall be in close proximity
to the equipment, within easy reach of the operator; and marked as the
disconnecting device for the equipment.
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.
Verify that there is an easy access to the main power switch, to the
water cut-off valve and to the current leakage safety relay.
Make sure while placing the autoclave, to leave space around the
machine, to give the technician access to service the machine.

Page 12 of 83 Pages
All water connections to autoclave must be performed through
"BACK FLOW PREVENTION SYSTEM" only, as per IEC 61770.
3.10 Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
On-Off

Page 13 of 83 Pages
FRONT VIEW
No. Description
1
Front leg
2
Rear leg
3
Left service door
4
Left service door grip
5
Service door lock screws
6
Door cover
7
Pressure gauge
8
Display
9
Keyboard
10
Printer cover
11
Paper slot and paper cutter
12
Printer
13
Main switch
14
RJ45 connector
15
USB socket
9 105 6 7 8
11
14
15
4
3
2
1
12
13

Page 14 of 83 Pages
REAR VIEW
No. Description
1 Fan grill
2 Circuit breaker
3 Electrical cord
4 City (tap) water inlet
5 Compressed air inlet
6 Drain outlet
7 Air pressure regulator
8 Air pressure gauge
9 Mineral free water inlet
10 Safety relief valve
7
8
9
10
1
2
3
4
5
6

Page 15 of 83 Pages
OVERALL DIMENSIONS DRAWING (mm)
5075ELV 5050ELV

Page 16 of 83 Pages
3.11 Water Quality
3.11.1 Water for Steam Generation
The distilled or mineral – free water supplied to the autoclave
should have the physical characteristics and maximum
acceptable level of contaminants indicated in the table below:
Physical Characteristics and Maximum acceptable
contaminants levels in steam for sterilizers
(According to EN 13060:2004).
Element Condensate – allowable
content
Silicium oxide. SiO2≤0.1 mg/kg
Iron ≤0.1 mg/kg
Cadmium ≤0.005 mg/kg
Lead ≤ 0.05 mg/kg
Rest of metals except iron,
cadmium, lead ≤0.1 mg/kg
Chloride (Cl) ≤0.1 mg/kg
Phosphate (P2O5)≤0.1 mg/kg
Conductivity (at 20°C) ≤3 μs/cm
pH value (degree of acidity) 5 to 7
Appearance Colourless clean without
sediment
Hardness (Σ Ions of alkaline
earth) ≤0.02 mmol/l
Compliance with the above data should be tested in accordance
with acknowledged analytical methods, by an authorized
laboratory.
Attention:
We recommend testing the water quality once a month. The
use of water for autoclaves that does not comply with the table
above may have severe impact on the working life of the
sterilizer and can invalidate the manufacturer’s guarantee.
3.11.2 Drain Cooling
The feed water supplied to the drain cooling must meet the
following requirements:
Hardness: 0.7 - 0.2 mmol/l.
Water temperature shall not exceed 15°C (59°F).

Page 17 of 83 Pages
3.11.3 Reverse Osmosis
A Reverse Osmosis (RO) system may be used to improve the
quality of the water used to generate steam in the autoclave
chamber.
In RO, the water is forced through a semi-penetrable membrane,
which filters out contaminants to a high degree of efficiency. In
deionisation (DI) ions and charged particles are removed either
by electric fields or by ion exchange in resin beds.
Although the RO cannot normally attain the degree of purity
possible with the DI methods, it is more than adequate for the
feed water intended for clean-steam generators.
Moreover the RO has several advantages:
1. RO is cheaper to install and to run than DI.
2. RO removes particulate matter, organic molecules and
pyrogens that DI cannot remove
3. RO water is less corrosive to steel and copper than DI
water.
4. RO maintenance requirements are less demanding than
those of the DI units.
Therefore the use of mineral free water will contribute to better
performance and longer life of the autoclave.
3.12 Safety Features
This autoclave includes built-in safety features such as:
Error message display.
Electronic pressure and temperature measurement.
Safety relief valve to avoid build-up of excessive pressure.
Door switches enabling operation to be started only when the door is
closed.
Water level safety device.
Excess temperature protection.

Page 18 of 83 Pages
3.13 Description of Operation
3.13.1 Heat
The ELV-D vertical autoclaves are equipped with immersion
type, heating elements. After water has been introduced to the
chamber and the unit has been activated, the heating elements
begin to heat. The temperature and pressure in the chamber
increase until appropriate levels are reached. Sensors located
inside the chamber control the temperature and pressure levels.
3.13.2 Sterilization
The sterilization temperature is factory set at 134C (273F) for
instruments and at 121C (250F) for liquids and other materials
for which this temperature is appropriate. These settings may be
modified before each cycle. When sterilization temperature is
reached, the timed sterilization cycle begins.
3.13.3 Cooling
The autoclave is designed to operate two liquid cooling cycles,
as follows:
3.13.3.1 Sealed bottles (cooling with compressed air)
On completion of the sterilization stage, feed water
starts flowing through the cooling coil mounted
around the outer side of the chamber.
Compressed air is injected inside the chamber and
keeps a constant air pressure to balance the internal
pressure of the liquids inside the bottles. Compressed
air is passed through a 0.2µ microbiological filter.
When temperature of the liquids reaches the final set
temperature, the cooling stage is completed, flowing
water and compressed air is stopped, pressure in the
chamber goes down to atmospheric pressure.
At this stage, the door of the autoclave can be opened
and the sterilized materials can be taken out of the
chamber.
3.13.3.2 Unsealed bottles (cooling without compressed air)
On completion of sterilization, steam is exhausted
from the chamber at a slow rate. When chamber
pressure goes down to atmospheric pressure, water
starts flowing through the cooling coil mounted
around the outer side of the chamber. On conclusion
of the cycle the water flow is stopped automatically,
process is completed and it is possible to open the
door and take out the sterilized goods from the
chamber.
3.13.4 Exhaust
When the timed sterilization cycle is complete, the unit enters
into the exhaust stage, provided that a program other than the
liquid program was selected. The steam is exhausted from the
chamber, bringing the internal pressure down to atmospheric
pressure.